Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures

Phase 3CompletedNCT00419393

UCB Pharma190 enrolled

Overview

To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

190

Conditions

Epilepsy

Interventions

Keppra XR (Levetiracetam XR)DRUG

500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who were randomized into study N01280 \[NCT00419094\], and completed the 2 week up titration period Exclusion Criteria: * Subjects who did not meet the inclusion/exclusion criteria for N01280 \[NCT00419094\] * Subjects who were discontinued prior to the end of titration period

Locations (35)

Unnamed facility

Dothan, Alabama, United States

Outcomes

Primary Outcomes

Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)

An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Time frame: Duration of the Treatment Period (6 months-2 years)

Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)

A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.

Time frame: Duration of the Treatment Period (6 months-2 years)

Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period

Time frame: Duration of the Treatment Period (6 months-2 years)

Secondary Outcomes

Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months

Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.

Time frame: Study entry through 6 months

Data from ClinicalTrials.gov

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